Module 14: Design Development and Certification of Medical Devices

17/11/2023

Device material identification, chemical characterisation

• Same as in existing device? • Same chemical composition? • Manufacturing and sterilisation same? • Is body contact the same?

YES

Is there justification for risk assessment? NO

Conduct biological evaluation

The Organisation for Professionals in Regulatory Affairs

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Is there justification for risk assessment?

• Do data exist for all chemicals in the material? • Do the data apply to chemical mixtures? • Are data relevant for dose and route of exposure?

NO

YES

Conduct biological evaluation

Perform further evaluation based on chemical nature of materials, type and duration of contact

The Organisation for Professionals in Regulatory Affairs

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